Download Drug Information Sheet("Kusuri-no-Shiori") Internal Published: 05

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 05/2016
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,
patients should understand their medication and cooperate with the treatment.
Brand name:Tagrisso Tablets 40mg
Active ingredient:Osimertinib mesilate
Dosage form:bright grayish yellowish red round tablet, diameter: approx. 9 mm,
thickness: approx. 4.0 mm
Print on wrapping:(face)タグリッソ 40 mg, タグリッソ, (back)TAGRISSO 40 mg, タグリッソ
40 mg
Effects of this medicine
This medicine selectively inhibits epidermal growth factor receptor (EGFR) tyrosine kinase to decrease the
proliferative capacity of tumor cells with T790M gene mutations and active mutations.
It is usually used to treat inoperable or recurrent non-small cell lung cancer with EGFR T790M mutation resistant to
EGFR tyrosine kinase inhibitors.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have or have a medical history of interstitial lung disease.
If you have liver dysfunction.
If you have a risk of QT interval prolongation or a medical history of QT interval prolongation.
・If you are pregnant, possibly pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal
effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is<<
to be written by a healthcare professional>>
・In general, for adults, take 80 mg as osimertinib at a time, once a day. However, the dosage may be decreased
according to your symptoms. If adverse reactions occur, the dosage may be decreased to 1 tablet (40 mg) at a
time, once a day according to your condition. This medicine contains 40 mg of the active ingredient in a tablet.
Strictly follow the instructions.
・If you miss a dose, take the missed dose as soon as you remember. However, if it is almost time for the next dose,
skip the missed dose and follow your regular dosing schedule. You should not take two doses at one time.
・If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
・Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
・This medicine may cause serious adverse reactions. You should receive an explanation until you fully understand
the precautions and other important points.
・If you may possibly be pregnant, or if your partner may possibly be pregnant, use birth control.
・Avoid taking any food containing St. John's wort, since it may diminish medicinal effects.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash/acne, nail disorder (including nail disease), diarrhea,
skin dryness/eczema and interstitial lung disease. If any of these symptoms occur, consult with your doctor or
pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated
in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor
immediately.
・shortness of breath, breathing difficulty, cough, fever [interstitial lung disease]
・palpitation, dizziness, light headedness, faint [QT interval prolongation]
・nose bleeding, bruise, fever, dizziness [decreased platelets, decreased neutrophil cell, decreased white blood cell,
anemia]
・general malaise, yellow discoloration of the skin and the white of eyes, yellow discoloration of urine, nausea,
vomiting, loss of appetite, itch [liver dysfunction]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your
doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
・Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
・Discard the remainder. Do not store them. Ask your pharmacy or medical institution on how to discard the
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remainder.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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